Medical records received 17 june 2019 and were reviewed 06 september 2019 for mdr reportability.On (b)(6) 2014, the patient underwent total left knee arthroplasty due to osteoarthritis.It was noted the patella was resurfaced.The surgeon reported no intraoperative complications and patient was transferred to recovery in stable condition.Attune knee components, and smartset cement x 2 were implanted in the procedure.On (b)(6) 2014, the patient underwent a left knee revision.There were no operative notes provided with the medical records.Doi: (b)(6) 2014, dor: (b)(6) 2014 (lt knee).
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Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: a previous dhr review (b)(4), did not reveal any related manufacturing deviations or anomalies on the reported product code 545035500, lot number 7795159 combination.
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